Disability Adjusted Life Years of Sub-arachnoid Hemorrhage in Senegalese CohortNCT05016635
Disability-adjusted Life Years in a Senegalese Cohort of Patients With Subarachnoid Hemorrhage
An observational study of Disability Adjusted Life Years of Sub-arachnoid Hemorrhage in Senegalese Cohort, run by Association of Future African Neurosurgeons, Yaounde, Cameroon at 1 site in Senegal.
Trial summary
Subarachnoid hemorrhage (SAH) is the extravasation of blood into the subarachnoid space from traumatic or nontraumatic origin. There is a paucity of data on the burden of SAH in African countries. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Disability Adjusted Life Years of Sub-arachnoid Hemorrhage in Senegalese Cohort
- How many people
- 388 participants
- Where
- 1 siteSenegal
- Study dates
- 26 Apr 2021to 16 Aug 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: We recruited 448 patients between 2011 and 2020. However, 60 patients (13.4%) had incomplete records and were excluded from the analysis. Herein we present the retrospective analysis of the 388 patients (86.6%) with complete records. We received a median of 40.0 patients annually (IQR=51.5), and a peak was observed in 2017 when 76 SAH patients were admitted at our institution.
Who may be able to join
- Sub-arachnoid Hemorrhage admission
Who cannot join
- Not admitted for sub-arachnoid hemorrhage
Trial locations and contacts
1 site in 1 country.
About this study
Subarachnoid hemorrhage (SAH) is the extravasation of blood into the subarachnoid space from traumatic or nontraumatic origin. There is a paucity of data on the burden of SAH in African countries. In this study, we analyzed data from patients in the largest neurovascular center in Senegal to determine the sex- and age-adjusted burden of SAH in Senegal.
Read the detailed description
The Fann Teaching Hospital (Dakar, Senegal) institutional review board authorized this study. Consent was obtained from adult patients and the parents/legal guardians of children. Patient data were stored in a password-protected Excel spreadsheet, and this spreadsheet was stored on a hard drive. Only the authors had access to the data.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sub-arachnoid Hemorrhage Patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability Adjusted Life Years
Mortality and Morbidity
Measured: 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start26 Apr 2021
- Primary completion16 Aug 2021
- Study completion16 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disability Adjusted Life Years of Sub-arachnoid Hemorrhage in Senegalese CohortStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Other
- Enrolment
- 388 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Association of Future African Neurosurgeons, Yaounde, Cameroon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05016635
- Sponsor's protocol ID
- AFANSEN1
- Status last verified
- Aug 2021
- First submitted
- 17 Aug 2021
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disability-adjusted Life Years in a Senegalese Cohort of Patients With Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT05016635
- Acronym / sponsor ID
- AFANSEN1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 388 participants (actual)
- Lead sponsor
- Association of Future African Neurosurgeons, Yaounde, CameroonUniversity, hospital or other
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 16 Aug 2021 (actual)
- Study completion
- 16 Aug 2021 (actual)
- First posted
- 23 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subarachnoid hemorrhage (SAH) is the extravasation of blood into the subarachnoid space from traumatic or nontraumatic origin. There is a paucity of data on the burden of SAH in African countries. In this study, we analyzed data from patients in the largest neurovascular center in Senegal to determine the sex- and age-adjusted burden of SAH in Senegal.
Detailed description
The Fann Teaching Hospital (Dakar, Senegal) institutional review board authorized this study. Consent was obtained from adult patients and the parents/legal guardians of children. Patient data were stored in a password-protected Excel spreadsheet, and this spreadsheet was stored on a hard drive. Only the authors had access to the data.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sub-arachnoid Hemorrhage Patients | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We recruited 448 patients between 2011 and 2020. However, 60 patients (13.4%) had incomplete records and were excluded from the analysis. Herein we present the retrospective analysis of the 388 patients (86.6%) with complete records. We received a median of 40.0 patients annually (IQR=51.5), and a peak was observed in 2017 when 76 SAH patients were admitted at our institution.
Key inclusion criteria (1 listed)
- Sub-arachnoid Hemorrhage admission
Key exclusion criteria (1 listed)
- Not admitted for sub-arachnoid hemorrhage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disability Adjusted Life Years
Time frame: 9 years
Mortality and Morbidity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disability Adjusted Life Years of Sub-arachnoid Hemorrhage in Senegalese Cohort, run by Association of Future African Neurosurgeons, Yaounde, Cameroon at 1 site in Senegal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Senegal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability Adjusted Life Years (time frame: 9 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2021.